title: Pharmacokinetic study of minipooled solvent/detergent-filtered cryoprecipitate factor VIII.
abstract: Eighteen cryoprecipitate minipools, each made of 30 units of low volume, concentrated cryoprecipitate, have been treated by solvent-detergent and filtration (S/D-F) in a single-use CE-marked bag system. The S/D-F cryoprecipitate contained a mean of 10.5 IU mL⁻¹ factor VIII (FVIII), 17 mg mL⁻¹ clottable fibrinogen, and >10 IU mL⁻¹ von Willebrand factor ristocetin co-factor, and anti-A and anti-B isoagglutinins were undetectable. The products have been infused in 11 severe (FVIII <1%) haemophilia A patients (mean age: 17.4 years; mean weight: 57.6 kg) at a dose close to 40 IU kg⁻¹. Patients were hospitalized for at least 36 h to determine FVIII recovery, half-life and clearance. They were also closely monitored for possible adverse events. None of the infused patients demonstrated reactions or adverse events even though they did not receive anti-allergic drugs or corticosteroids prior to infusion. The mean recovery of FVIII 10 min postinfusion was 69.7%. Mean FVIII half-life was 14.2 h and clearance was 2.6 mL h⁻¹ kg⁻¹. All patients had a bleeding-free interval of 8-10 days postS/D-F cryoprecipitate infusion. The data show that S/D-F cryoprecipitate FVIII presents a normal pharmacokinetics profile, and support that it could be safely used for the control of acute and chronic bleeding episodes in haemophilia A patients.
authors.affiliation: Shabrawishi Hospital Blood Bank, Giza, Egypt.
authors.forename: M
authors.initials: M
authors.lastname: El-Ekiaby
authors.forename: H A
authors.initials: HA
authors.lastname: Goubran
authors.forename: M
authors.initials: M
authors.lastname: Radosevich
authors.forename: A
authors.initials: A
authors.lastname: Abd-Allah
authors.forename: A
authors.initials: A
authors.lastname: El-Ekiaby
authors.forename: T
authors.initials: T
authors.lastname: Burnouf
mesh_terms: D000293:Adolescent; D000328:Adult; D001793:Blood Preservation / Q000379:methods; D002648:Child; D005169:Factor VIII / Q000737:chemistry / Q000493:pharmacokinetics*; D005340:Fibrinogen / Q000737:chemistry / Q000493:pharmacokinetics*; D006207:Half-Life; D006467:Hemophilia A / Q000188:drug therapy / Q000378:metabolism*; D006801:Humans; D008657:Metabolic Clearance Rate; D012997:Solvents; D055815:Young Adult
chemical_list: D012997:Solvents; C026912:cryoprecipitate coagulum; D005169:Factor VIII; D005340:Fibrinogen